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Adverse Event Report

CIBA VISION MEMORY LENS INTRAOCULAR LENS   back to search results
Model Number U940A
Event Date 12/03/1999
Event Type  Other   Patient Outcome  Required Intervention;
Event Description

It was reported that, "in 1999, doctor implanted lens on the left eye of the pt. Phacoemulsification-corneal incision, no stitch, no complication. On 12/03/1999, pt's eye showed signs of severe inflammation, fibrinoid membrane intrapupiliary, posterior synechiae, sc geomycine and celectone chronodose, intravitreal cephalidal and geomycine-systemic antibiotics therapy-atropine, no culture. On 12/13/1999, fibrinoid reaction disappeared. ".

 
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Brand NameMEMORY LENS
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameCIBA VISION MEMORYLENS
Baseline Generic NameINTRAOCULAR LENS
Baseline Catalogue NumberCV232
Baseline Model NumberCV232
Baseline Device FamilyMEMORYLENS
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed01/03/2001
Manufacturer (Section F)
CIBA VISION
el jibaro industrial park
lot #2, po box 1358
cidra PR 00739
Manufacturer (Section D)
CIBA VISION
el jibaro industrial park
lot #2, po box 1358
cidra PR 00739
Manufacturer Contact
karen kulinski
11460 johns creek parkway
duluth , GA 30097
(678) 415 -4386
Device Event Key285351
MDR Report Key294814
Event Key276860
Report Number2648166-2000-00133
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation NO INFORMATION
Remedial Action Recall
Type of Report Initial
Report Date 09/07/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberU940A
Device Catalogue NumberU940A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/14/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on February 28, 2009

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